Physician Handbook

There is an Institutional Review Board (IRB) to review all biomedical and behavioral research involving human beings.  The IRB is composed of not only members of the Medical Staff but also individuals of varying backgrounds including at least one person not affiliated with Mercy and at least one person with no scientific background.  This Board is required to abide by the following federal guidelines:

1. All research involving human beings is subject to IRB review.  Some projects may be exempt from IRB review if patient identity is protected.  Such projects may include the study of existing data, records, pathological specimens, educational tests, interviews, or observational research not involving sensitive subjects (such as drug or alcohol use or other matters that place patients at risk of liability or could be damaging to financial standing, employability or reputation).  The opinion of the IRB chairperson should be sought by the investigator regarding exemption.
2. Informed consent will be obtained from all subjects participating in any research and documented in writing.  This consent shall include a clear and understandable statement of the potential risks and benefits of the proposed research, and will mention alternative treatments.   This consent will include a statement that the subject's participation is voluntary and that refusal to participate or continue to participate will not cause any loss of rights to treatments.
3. All active approved projects shall be reviewed at least annually.
4. Records shall be kept of all research proposals reviewed.
5. Neither the Medical Staff nor the Board of Trustees may authorize, or approve continuation of, research that the IRB has not approved or for which IRB approval has been suspended or terminated.

Human Protections Administrator:

Brenda Schulkind
Medical Affairs
879-3357
schulkindb@mercyme.com

IRB Chairperson:

Roger Inhorn, MD
Oncology Department
879-3949
inhornr@mercyme.com